NeoPharm Investigators Present Preliminary Phase I Data of Cintredekin Besudotox in the Treatment of Malignant Glioma at Initial Diagnosis.
--Poster Presentation at the 55th Annual Meeting of the Congress of Neurological Surgeons
--No Unexpected Types of Adverse Events To Date in the Study
--Multimodality Treatment Regimen with Cintredekin Besudotox may be Feasible
NeoPharm, Inc. (Nasdaq:NEOL) today announced the presentation of initial safety data from a Phase I study of cintredekin besudotox in the treatment of newly diagnosed malignant glioma patients at the 55th Annual Meeting of the Congress of Neurological Surgeons (CNS) being held in Boston from October 8-13, 2005.
The main objective of this study is to assess the safety and tolerability of cintredekin besudotox administered via Convection Enhanced Delivery (CED) followed by Radiation Therapy (RT) with or without Temozolomide (TMZ or Temodar) in patients with newly-diagnosed malignant glioma. The secondary objective is to determine the maximum-tolerated concentration, and the tertiary endpoint is to assess response to therapy as measured by overall survival.
"The results to date of this Phase I study of cintredekin besudotox provide preliminary support to the feasibility of future multimodality therapy consisting of surgery followed by cintredekin besudotox, radiation therapy and temozolomide in the treatment of newly diagnosed patients with malignant glioma. The study complements the ongoing Phase III PRECISE clinical trial and provides initial evidence on the potential for broader utilization of cintredekin besudotox in the treatment of malignant glioma from initial diagnosis to recurrent disease," commented Michael Vogelbaum, M.D., Ph.D., Director, Center for Translational Therapeutics, Associate Director of Neurosurgical Oncology, Brain Tumor Institute, Departments of Neurosurgery and Cancer Biology, Cleveland Clinic Foundation. Dr. Vogelbaum is co-Principal Investigator for the Phase I study along with John Sampson, M.D., Ph.D., Duke University.
The study mirrors the procedure in the PRECISE trial for first recurrent glioblastoma multiforme. Patients with newly-diagnosed malignant glioma undergo a gross total resection of contrast-enhancing tumor followed by peritumoral infusion of cintredekin besudotox via CED. Separate cohorts of patients in this study receive either 0.25 microgram/mL or 0.5 microgram/mL of study drug followed by RT with or without adjuvant TMZ.
Twelve patients have been enrolled in the study to date. Adverse events (AEs) considered related to cintredekin besudotox were consistent with AEs observed in Phase I studies of cintredekin besudotox administered as monotherapy in patients with recurrent malignant glioma. No Grade 3-4 hematological toxicities related to administration of TMZ were observed.
Based on the preliminary data, the investigators believe that CED of cintredekin besudotox followed by RT with or without TMZ offers promise as a feasible treatment regimen in patients with newly-diagnosed malignant glioma. The potentially next and final cohort of 0.5 microgram/mL cintredekin besudotox followed by RT and TMZ is anticipated to soon open for enrollment. Patients continue to be followed for survival which has extended at this time to beyond 1 year.
About Cintredekin Besudotox (IL13-PE38QQR)
NeoPharm has determined that the key to making a useful tumor-targeting drug is a targeting mechanism that selects tumor cells while bypassing healthy ones. Cintredekin besudotox is a recombinant protein consisting of a single molecule composed of two parts: a tumor-targeting molecule (Interleukin-13) and a cytotoxic agent (Pseudomonas Exotoxin, or PE). IL13 receptors are present in appreciable numbers on malignant glioma cells, but only to a minimal amount if at all on healthy brain cells. The IL13 portion binds to receptors on the tumor like a key fits into a lock. The cancer cell latches onto and absorbs the IL13 and the attached PE, causing destruction of the cancer cell. Healthy brain cells appear to be unharmed because they do not internalize the PE. Cintredekin besudotox is currently being tested as a treatment for patients with recurrent malignant glioma in the Company's ongoing Phase III PRECISE trial. Cintredekin Besudotox has received orphan drug designation in Europe and the U.S., and fast track drug development program status from the U.S. Food and Drug Administration (FDA). NeoPharm's cintredekin besudotox development program was also selected to participate in the FDA Continuous Marketing Application Pilot 2 Program.
PRECISE, an acronym for Phase III Randomized Evaluation of Convection Enhanced Delivery of IL13-PE38QQR with Survival Endpoint, is a randomized, controlled Phase III clinical trial. It is designed to compare overall survival, drug safety and quality of life of patients receiving cintredekin besudotox with patients receiving GLIADEL(R) Wafer in the treatment of first recurrent GBM following surgical tumor resection (removal). Patients are randomized so that 200 patients receive cintredekin besudotox via CED using catheters placed following the resection, and 100 patients receive GLIADEL(R) Wafer placed at the time of resection. Enrollment in PRECISE, www.precisetrial.com, is expected to be completed in the fourth quarter of 2005.
About NeoPharm, Inc.
NeoPharm, Inc., based in Lake Forest, Illinois, is a publicly traded biopharmaceutical company dedicated to the research, development and commercialization of new and innovative cancer drugs for therapeutic applications. The Company has a portfolio of cancer compounds in various stages of development. Additional information can be obtained by visiting NeoPharm's Website at www.neophrm.com.
Forward Looking Statements - This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The Company has tried to identify such forward-looking statements by use of such words as "expects," "intends," "hopes," "anticipates," "believes," "could," "may," "evidences" and "estimates," and other similar expressions, but these words are not the exclusive means of identifying such statements. Such statements include, but are not limited to, any statements relating to the Company's drug development program, including, but not limited to the PRECISE trial and other clinical studies involving cintredekin besudotox, future patient enrollment in the Company's PRECISE trial or other clinical studies involving cintredekin besudotox, and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in financing, development, testing, obtaining regulatory approval, production and marketing of the Company's drug and non-drug compounds, including, but not limited to, cintredekin besudotox, uncertainty regarding the availability of third party production capacity, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug and non-drug compounds, including, but not limited to, cintredekin besudotox, that could slow or prevent products coming to market, uncertainty regarding the Company's ability to market its drug and non-drug products, including, but not limited to, cintredekin besudotox, the uncertainty of patent protection for the Company's intellectual property or trade secrets, including, but not limited to, cintredekin besudotox, and other risks detailed from time to time in filings the Company makes with the Securities and Exchange Commission including its annual reports on Form 10-K and quarterly reports on Forms 10-Q. Such statements are based on management's current expectations, but actual results may differ materially due to various factors, including those risks and uncertainties mentioned or referred to in this press release. Accordingly, you should not rely on these forward-looking statements as a prediction of actual future results.
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|Date:||Oct 10, 2005|
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